Department of Medical Oncology-Breast Cancer Unit, Insitut Catala d'Oncologia (ICO)-H.U.Bellvitge- IDIBELL, Avinguda Gran Via 199-203, 08908-L'Hospitalet de Llobregat, Barcelona, Spain.
Research Unit, Institut Català d'Oncologia-(ICO) L'Hospitalet, Barcelona, Spain.
BMC Pharmacol Toxicol. 2019 Nov 21;20(1):68. doi: 10.1186/s40360-019-0367-x.
Eribulin improves survival in pre-treated HER2-negative advanced breast cancer (ABC). However, limited data exist on co-morbidities and central nervous system (CNS) efficacy. The purpose of this study was to review eribulin's efficacy and safety in everyday clinical practice with special focus on age, body mass index (BMI) and central nervous system (CNS) activity.
An observational study was conducted in a series of HER2-negative ABC patients treated from January'14-December'17 outside a clinical trial. Objective Response Rate (ORR), Progression Free Survival (PFS), Overall Survival (OS), and association of clinical and pathological variables with outcome were evaluated.
Ninety-five women were treated with at least one cycle of eribulin. Median age was 57 (33-83), and 18% were obese. Median number of prior chemotherapies for ABC was 3 (2-5) and 76% of patients had visceral metastases, including 21% with CNS involvement. Most tumors were estrogen receptor-positive (79%). ORR and stable disease (SD) at 6 months were 26.2 and 37.5%, respectively. Remarkably, relevant CNS efficacy was observed with eribulin: 20% of patients obtained partial response and 25% SD. Treatment was generally well tolerated and manageable, with 29% grade 3 and 10.9% grade 4 toxicities. Median PFS and OS were 4.1 months (CI95% 3.2-4.9) and 11.1 months (CI95% 9.5-14.7), respectively. Triple-negative disease, > 2organs involved and being younger than 70 years old were independent prognosis factors for worse OS in multivariate analysis. Most patients (75%) progressed in pre-existing metastases sites.
In everyday clinical practice, eribulin's efficacy seems similar to pivotal trials. CNS-efficacy was observed. TNBC, > 2 organs involved and being younger than 70 years old were independent prognosis factors for worse OS. Remarkably, less incidence of grade 4-toxicity compared to previous studies was found.
依立布林可改善先前治疗的人表皮生长因子受体 2 阴性晚期乳腺癌（ABC）患者的生存率。然而，关于合并症和中枢神经系统（CNS）疗效的数据有限。本研究的目的是在日常临床实践中回顾依立布林的疗效和安全性，特别关注年龄、体重指数（BMI）和中枢神经系统（CNS）活性。
在一项观察性研究中，纳入了 2014 年 1 月至 2017 年 12 月期间在临床试验之外接受治疗的 HER2 阴性 ABC 患者系列。评估客观缓解率（ORR）、无进展生存期（PFS）、总生存期（OS），并分析临床和病理变量与结果的关系。
95 例患者至少接受了一个周期的依立布林治疗。中位年龄为 57 岁（33-83 岁），18%的患者肥胖。先前治疗 ABC 的中位数化疗次数为 3 次（2-5 次），76%的患者有内脏转移，包括 21%有中枢神经系统受累。大多数肿瘤为雌激素受体阳性（79%）。6 个月时的 ORR 和疾病稳定（SD）率分别为 26.2%和 37.5%。值得注意的是，依立布林具有显著的 CNS 疗效：20%的患者获得部分缓解，25%的患者疾病稳定。治疗总体耐受良好，管理方便，3 级毒性发生率为 29%，4 级毒性发生率为 10.9%。中位 PFS 和 OS 分别为 4.1 个月（95%CI95%3.2-4.9）和 11.1 个月（95%CI95%9.5-14.7）。多因素分析显示，三阴性疾病、>2 个器官受累和年龄<70 岁是 OS 较差的独立预后因素。大多数患者（75%）在先前转移部位进展。
在日常临床实践中，依立布林的疗效似乎与关键性试验相似。观察到 CNS 疗效。TNBC、>2 个器官受累和年龄<70 岁是 OS 较差的独立预后因素。与之前的研究相比，发现 4 级毒性的发生率显著降低。
